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Administrator
Posts: 578
Registered: ‎02-22-2010
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USP 797 Isolator Webinar

[ Edited ]

Thanks for joining Eric Kastango on "The 5 W's of Isolators and Complying with USP Chapter 797."


View the on-demand recording or download the slides. 

Have a question for Eric? Post it here and he will do his best to answer your questions.

Occasional Visitor
Posts: 2
Registered: ‎04-27-2011
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Re: USP 797 Isolator Webinar

Thank you for a great presentation.  With the suggestion of wiping off products introduced to the ante chamber in addition to spraying with alcohol.  What suggestion can you give for the wipe to be used.  How often should this be changed? 

Occasional Advisor
Posts: 5
Registered: ‎01-19-2011
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Re: USP 797 Isolator Webinar

While we were performing our Glove fingertip testing, we had our all compounders to perform a Surface plate testing as well.

We had 8 staff members perform this and all eight grew out mild gram negative rods, even some after thorough cleaning.

Do you think the plates are contaminated or is our cleaning agent not working for us?

Thanks,

Joyce Glisson

Upson Regional Medical Center

Occasional Advisor
Posts: 8
Registered: ‎07-13-2011
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USP 797 Isolator WEbinar

Eric,

 

One of the slides at end of presentation mentioned removing overwrap in the pass thru vs. direct compounding area. Wondering what your thoughts are on this? Everything I have read in the past recommended removing overwrap only in DCA even though our hood does maintain ISO Class 5 in the pass-thru area.

Administrator
Posts: 578
Registered: ‎02-22-2010
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Re: USP 797 Isolator Webinar

Here are some questions from our live presentation:

 

Q: Would a CACI that is not vented to the outside be considered a CAI only, or can you still call it a CACI?

 

Q: Our paper work from our certifier states that the clean zone was tested "at rest", not during active compounding conditions. Is this acceptable? I guess I am still unclear. Our air particle samples show  ISO class 8 for both CAI and CACI rooms. Is this is not acceptable for CACI room, based on one of your slides?

 

Q: Are we supposed to wipe down each alcohol wipe package before bringing them into the CAI or CACI? I also thought bacillus was a spore that was not disinfected by alcohol. So should we be wiping alcohol wipes with a sterile bleach spray?

 

Q: Are you not allowed to open the CAI to clean so long as you are gowned, masked, gloved and hair net?

 

Q: Is it okay to replace gaunlet gloves with sterile gloves typically used in IV room?

 

Q: Should outer wrap be taken off in the pass through or the main chamber? If taken off in the main chamber, should they be moved out of the main chamber before starting the compounding procedure?

Expert
Posts: 1,166
Registered: ‎02-23-2010

Re: USP 797 Isolator Webinar

Maria,

 

Thanks for your compliment.  Any type of lint-free wipe (there are a number of vendors) can be used.  I would change the wipe frequently, typically after a batch of components have been brought into the ante chamber.  You will use a bunch of them each day. 

Eric S. Kastango, MBA, RPh, FASHP

It's all about the patient.
Expert
Posts: 1,166
Registered: ‎02-23-2010

Re: USP 797 Isolator Webinar

Joyce,

 

This is not a good situation but tells me you are using robust media plates for your environmental testing. Where did you get the plates from?  They could have been contaminated prior to use and you can pre-incubate the plates (media side inverted) at 30 C for 48 days prior to use to identified bad plates from the manufacturer.  Are you having similar issues with air sampling?   Were the gloves sterile?  You might try a different lot of gloves.  Do you have any sources of tap water in your sterile compounding space?  What type of cleaning agent are you using?  If you are using anything mixed with tap water, that can be a likely source of contamination. I had a client have a bunch of nasty germ negative organisms growing in their BSCs and we identified their choice of cleaning agent/solution (Palmolive dish soap and tap water) as the source.  Do not use any household cleaning agents since they are not designed to be used in the sterile compounding area. You want to use a robust germicidal detergent prepared in sterile water for irrigation or injection.  I would like to hear how you make out with this issue.  Thanks. 

Eric S. Kastango, MBA, RPh, FASHP

It's all about the patient.
Expert
Posts: 1,166
Registered: ‎02-23-2010

Re: USP 797 Isolator WEbinar

Karla,

 

I absolutely agree with you that the packaging around sterile devices are only opened in the main chamber/DCA.  Other components/supplies like tubing, bag overwraps, etc. can be removed from their packaging and placed in the ante chamber to minimize the contamination and clutter. 

Eric S. Kastango, MBA, RPh, FASHP

It's all about the patient.
Expert
Posts: 1,166
Registered: ‎02-23-2010

Re: USP 797 Isolator Webinar

Q: Would a CACI that is not vented to the outside be considered a CAI only, or can you still call it a CACI?

 

A: The CACI should operate under negative-pressure for containment purposes and CAI operates under positive pressure whether they are vented to the outside or not.

 

Q: Our paper work from our certifier states that the clean zone was tested "at rest", not during active compounding conditions. Is this acceptable?

 

A: NO!  The chapter is clear on the testing requirements (under dynamic conditions) and your certifer if they knew what the standard required would know that this not acceptable.  

 

Q: Our air particle samples show  ISO class 8 for both CAI and CACI rooms. Is this is not acceptable for CACI room, based on one of your slides?

 

A: If you isolator cannot be meet the criteria stipulated in the chapter (3 requirements), then the isolators need to be located in an ISO Class 7 buffer area.  If they do, and the only way to know this is if your certifier tested the isolators according to CETA gudielines,  then the ISO Class 8 room is ok.  Addtionally and something I realized that I forgot to talk about was the placement of the CACIs.  CACIs need to be located in a negative-pressure room with at least 12 air changes per hour because you are handling and storing HDs.  This room does not have to be classified.

 

Q: Are we supposed to wipe down each alcohol wipe package before bringing them into the CAI or CACI? I also thought bacillus was a spore that was not disinfected by alcohol. So should we be wiping alcohol wipes with a sterile bleach spray?

 

A: If spores are a concern, the use of a sterile sporicidal agent is highly recommended.  Any component, package or ingredient needs to be wiped down prior to placing them into the ISO Class 5 device. 

 

Q: Are you not allowed to open the CAI to clean so long as you are gowned, masked, gloved and hair net?

 

A: Since you are dealing with a CAI (positive-pressure), you can open it but should leave it running and be properly garbed in order to do a thorough cleaning. 

 

Q: Is it okay to replace gaunlet gloves with sterile gloves typically used in IV room?

 

A: You can replace the gauntlet gloves with any type of sterile glove that works and fits you and your staff. 

 

Q: Should outer wrap be taken off in the pass through or the main chamber? If taken off in the main chamber, should they be moved out of the main chamber before starting the compounding procedure?

 

A: See response to an earlier question. I would minimize the amount of trash in the main chamber when compounding. 

Eric S. Kastango, MBA, RPh, FASHP

It's all about the patient.
Moderator
Posts: 51
Registered: ‎02-19-2010
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Re: USP 797 Isolator Webinar

What are the pressure differential monitoring requirements when using isolators?

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